Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

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Philips halting sleep apnea device sales amid FDA consent decree

The deal aims to resolve concerns over the company's breathing device division after complaints and a controversial recall brought the attention of government watchdogs.
 

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Cardiologists speak out about reimbursement cuts, say Congress ‘left clinicians holding the bag’

When Congress passed its latest continuing resolution to avoid a government shutdown, it provided no relief for cardiologists and other physicians impacted by ongoing Medicare reimbursement cuts. The American College of Cardiology responded to this development with yet another plea for change. 

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FDA flags defective packaging of Exactech shoulder joint devices

Equinoxe Shoulder System joint replacement devices have shipped in bags missing a crucial oxygen barrier, potentially putting patients at risk.

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Government watchdog takes up FDA recall inquiry following report

The reporting detailed Philips' delay in issuing a recall of its breathing machines, drawing the ire of two U.S. Senators who have been pushing for an investigation into how the FDA handles oversight.

Richard Heller, MD, RSNA Board member, associate chief medical officer for health policy and communications, and national director of pediatric radiology at Radiology Partners, explains some insurance companies are trying to take advantage of the No Surprises Billing Act by telling radiology practices they need to accept lower rates to remain part of the providers in-network.

Radiologists urged to report insurance companies forcing lower reimbursements due to No Surprises Act

Some payers are taking advantage of the NSA by forcing practices to accept lower rates to remain in-network, says Rad Partners' Richard Heller, MD. 

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CES speakers talk about AI in health, need for trust

Keynote speakers noted the need to move at the “speed of trust” in order to reach potential for healthcare.

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FDA clears mass importing of Canadian drugs

Florida’s program is the first to get official approval in an effort to reduce drug costs.

Video interview with Radiology Business Management Association (RBMA) President Kit Crancer, and executive director of the Rayus Quality Institute, where he said the lack of federal policy on insurance coverage for diagnostic breast exams as opposed to screening exams

State legislation addresses gaps in breast imaging coverage, ensures affordable diagnostic exams

RBMA President Kit Crancer said a lack of federal policy has driven 20 states to adopt laws requiring that insurance cover the costs. 

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Around the web

Cardiovascular Business
Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

Cardiovascular Business
Cardiologist compensation still rising, especially in invasive and interventional cardiology

Updated compensation data includes good news for multiple subspecialties. The new report also examines private equity's impact on employment models and how much male cardiologists earn compared to females.

Cardiovascular Business
FDA’s tirzepatide decision creates uncertainty for patients—and leads to a lawsuit

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country. 

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